What the inspector wrote
Change control CC-24-031 to replace the filling machine PLC was raised on 14 March and approved on 2 April. Maintenance records show the PLC was replaced on 21 March and production resumed on 22 March. Three batches were manufactured on the modified equipment before the change control, including its validation impact assessment, was approved.
Cited against EU GMP Chapter 1, 1.4(xiii); Annex 15, 11
Why it was cited
The point of change control is that the assessment happens before the change. Implementing first and approving later turns the assessment into paperwork, and it means product was made on equipment whose validated state was, at that moment, unknown.
This finding almost always arrives with a second one: the batches made in the gap were released without a deviation being raised.
What would have prevented it
- Engineering and maintenance work orders that touch GMP equipment should require an approved change control number before work can be scheduled.
- Define clearly what counts as like-for-like, and have QA agree the classification, so urgent repairs have a fast lane that is still controlled.
- Batch release should include a check for open or recently approved changes on the equipment used.
Written from the deficiency categories published by EU and UK regulators. Details are illustrative and do not describe a specific named site.